Ribociclib Succinate

Treats hormone receptor (HR)-positive, human epidermal growth factor receptor 2…. Sold as Kisqali. Every FDA application for this active ingredient.

As of Nov 14, 2026, FDA lists 1 application for Ribociclib Succinate (sold as Kisqali), first approved Mar 13, 2017, with 7 new uses approved and 0 published complete response letters.

First approved: Mar 13, 2017
Applications: 1
New uses approved: 7
Complete response letters: 0
Medicare spending, 2025: $1.76B
First approved in the EU: Aug 22, 2017

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Kisqali	Part D	$1.76B	+127%	17,371

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

KISQALI 400 MG DAILY DOSE: $346.95 per unitBrand · new this year
KISQALI 600 MG DAILY DOSE: $289.72 per unitBrand · -1% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of neuroblastomaNovartis Pharmaceuticals Corporation · designated Nov 25, 2022

Approvals in the EU (EMA)

First approved in the EU 5 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Kisqali, new substanceNovartis Europharm Limited · Aug 22, 2017

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low TrialAnatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8 · National Cancer Institute (NCI)	Phase 3	Recruiting	Feb 6, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Mar 13, 2017	KisqaliNDA 209092 · New molecular entity	Novartis	15	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA